Biocon Biologics Limited (BBL) got off to a promising start to FY24 with an over two-fold increase in first-quarter revenues, truly reflecting the “Power of One” derived from the Company’s transformative acquisition of the global biosimilars of its long-term partner Viatris.
Driven by market share gains for its commercialized biosimilars in key markets and the consolidation of the acquired business, the Company’s revenues jumped 106% to Rs 2,015 crore.
Having completed the acquisition, Biocon Biologics is now progressing ahead of target in integrating the acquired business. On July 1, 2023, we successfully integrated the acquired business in over 70 Emerging Markets countries, allowing us to expand our reach and portfolio within these countries.
The successful first wave of integration has set the stage for the transition of the businesses in North America and Europe later this financial year. This will be a key milestone as the Advanced Markets contribute to 75% of BBL’s revenue.
Strong Demand in Advanced Markets; Successful Launch of Hulio in U.S.
As a fully integrated, global biosimilars player, Biocon Biologics is committed to fulfilling the unmet needs of patients globally.
In line with this commitment, we have built a good track record in the U.S. by providing affordable access to our high-quality biosimilars for Trastuzumab, Pegfilgrastim and Insulin Glargine.
Fulphila, our biosimilar Pegfilgrastim, has doubled its market share to 16% from a year ago in the U.S. market. It is now the leading biosimilar in its category. Similarly, the market share of Ogiviri (biosimilar Trastuzumab) has increased to 11% from 9% last year. Our branded biosimilar Glargine (Semglee) and unbranded Glargine have together garnered a market share of 12% in the U.S.
Building on our strong presence in oncology and diabetes, we have launched Hulio, a biosimilar to blockbuster biologic drug Humira®*, which expands our patient offerings in the U.S. to include a product for immunology.
In Europe, Hulio (bAdalimumab) is delivering significant growth in key markets, garnering a sizeable market share at 18% in Germany and 10% in France.
We continue to see a strong uptake for our other products such as Abevmy®, biosimilar Bevacizumab, in Europe where its market share has gone up to 6% from 1% last year.
Preparing for Stronger Growth in Emerging Markets
Emerging Market (EM) countries are our future growth drivers as demand for our flagship products such as recombinant human Insulin, biosimilar Glargine and biosimilar Trastuzumab continues to rise. We won several tenders for bTrastuzumab, bBevacizumab, bPegfilgrastim and bGlargine in some countries in LATAM and AFMET regions in Q1FY24. These tender wins, along with the successful integration of over 70 countries, position us well for business growth in these markets.
Other Highlights
Net R&D investments were Rs 259 crore, representing 13% of Biocon Biologics’ revenue for the first quarter. The strong revenue growth was supported by Core EBITDA of Rs 513 crore, with margins at 28%, which is reflective of the overall health of the business.
The revenues and margins for the quarter were impacted due to phasing of the tender business in Emerging Markets and higher rebates for Pegfilgrastim in the U.S., based on legacy contracts with select customers. This will normalize in the coming quarters.
A Robust R&D Pipeline
As an end-to-end biosimilars player, Biocon Biologics has a robust research and development backbone. Weare amongst the highest spenders on R&D in the Indian pharma sector, investing close to Rs 900 crore in R&D in FY23. The high level of R&D investments has ensured that Biocon Biologics is progressing well on the development of its key assets.
Our investments have led us to craft a differentiated and comprehensive portfolio of 20 biosimilars assets, spanning insulins, monoclonal antibodies (mAbs) and conjugated recombinant proteins, for diabetes, cancer, autoimmune diseases, ophthalmic conditions, bone health and other therapeutic areas. The addressable market for our biosimilars is estimated to grow over three times to USD 78 billion in the next five years. Eight biosimilars from this portfolio have been commercialized in global markets.
In Q1FY24, Yesafili, our biosimilar Aflibercept, became the first biosimilar to receive a positive opinion from the European Medicine Agency’s (EMA) CHMP, recommending approval. The clinical trials for biosimilar Ustekinumab and Denosumab also progressed well.
What Lies Ahead
The global biosimilars market is predicted to grow four-fold by 2030, benefitting from more than USD 200 billion of originator biologics losing exclusivity, according to a recent McKinsey study.
As a fully integrated, global biosimilars player, Biocon Biologics is well poised to tap this huge opportunity by introducing cost-effective, high quality biosimilars across a number of therapeutic areas. With 8 in-market and 12 pipeline products, offering a portfolio of 20 assets, Biocon Biologics is off to a transformational journey hereon.
*Reference product, a registered trademark of AbbVie Inc.
A Blog by Biocon 